MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-12 for 3G TORQUE 3 WITH FORMULA CG SEATING NA:3GTQ3-MCG 3GTQ3-MCG manufactured by Invacare Taylor Street.
[182965380]
Invacare is filing this medwatch in an abundance of caution due to the severity of the outcome. An invacare lawyer and expert examined the subject wheelchair on 2/10/2020. The expert for the patient's lawyer said incident was related to the (easy lock) bolt falling out before the auto accident. Invacare did not design or install the easy lock system. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182965381]
Invacare received a letter from an attorney advising that the end-user was severely injured in an automobile accident that occurred on (b)(6) 2019. Her vehicle hit a pole head-on when her wheelchair disengaged from a non-invacare locking system as she was driving. As a result of the accident, the end user suffered serious injuries, including bilateral ankle fractures, a femur fracture that required surgery, bilateral clavicle fractures and other on-going injuries that require extensive medical care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2020-00009 |
| MDR Report Key | 9701828 |
| Report Source | OTHER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-11-09 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2017-12-01 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3G TORQUE 3 WITH FORMULA CG SEATING |
| Generic Name | WHEELCHAIR, POWERED |
| Product Code | ITI |
| Date Received | 2020-02-12 |
| Model Number | NA:3GTQ3-MCG |
| Catalog Number | 3GTQ3-MCG |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-02-12 |